Asherman Syndrome
Conditions
Keywords
Asherman syndrome, Mindfulness, Anxiety, Depression, Quality of Life
Brief summary
The purpose of this study is to determine whether mindfulness based stress reduction are effective on improve anxiety, depression and quality of life in women with intrauterine adhesion
Detailed description
This is a parallel arm, randomized controlled trials, according to 1: 1 ratio assigned intrauterine adhesions patients to mindfulness based stress reduction group and wait-list control group.The study compared anxiety and depression levels and quality of life in patients with intrauterine adhesions before and after the completion of mindfulness based stress reduction program.Anxiety, depression and quality of life level measured by the Zung self-rating anxiety scale, Zung Self-Rating Depression Scale and The 36-item Short-Form Health Survey.
Interventions
OTHERMindfulness Based Stress Reduction
Mindfulness Based Stress Reduction programs have been shown to be effective, however, the potential benefits of Mindfulness Based Stress Reduction to decrease depression, anxiety, stress in other diseases. Therefore, the purpose of this study was to examine whether MBSR is effective, and has potential as an intervention to decrease depression, anxiety ,and to improve quality of life of intrauterine adhesion patients.
Sponsors
Yuqing Chen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 46 Years
Healthy volunteers
Yes
Inclusion criteria
1. Meet intrauterine adhesions diagnostic criteria of ESGE. 2. Patients with clear consciousness, can correct understanding related content of the questionnaire.
Exclusion criteria
1. Have a history of mental illness. 2. Receiving psychological treatment currently. 3. Have acute mental disorders. 4. Experienced special stress life events within six months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Zung Self-Rating Anxiety Scale Scores Before and After the Intervention | Baseline and 8 weeks | The full name of the scale called Zung Self-Rating Anxiety Scale.The ZSAS contains 20 questions. Each question is scored on a scale of 1-4 (never, some of the time, relatively often, most of the time). Fifteen questions involve the assessment of increasing anxiety levels, and five questions involve decreasing anxiety levels.Each items points accumulated as raw scores,the lowest raw score is 20 points, the highest raw score is 80 points. The raw scores multiply by 1.25, taking the integer part as the standard scores.The ZSAS standard scores were used to define four categories of anxiety severity: within normal rangeor no significant psychopathology (25-49points);presence of mild to moderate anxiety levels (50-59points); severe anxiety levels (60-69points); and presence of extreme depression (70-100points). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Menstruation Was Evaluated With Visual Analogue Scale (VAS) in Which the Menstruation Was Assessed by the Patients Themselves With 0 as Amenorrhea and 100 as Normal Menstruation | 3 months | — |
| Numbers of Participants With Reformation of Intrauterine Adhesions Were Counted by the Follow-up Hysteroscopy Was Performed in the Third Month After the Surgery | 3 months | — |
| The Zung Self-Rating Depression Scale Scores Before and After the Intervention | Baseline and 8 weeks | The full name of the scale called Zung Self-Rating Depression Scale.The ZSDS includes 10 positively worded items and 10 negatively worded items that assess symptoms of depression. Item responses are ranked from 1 to 4, and higher scores correspond to more frequent symptoms. For each item,patients give a score according to whether the item has occurred: 1 = never/very rarely; 2 = once in a while/some of the time/occasionally; 3 = relatively often/very often/often; 4 = most of the time/always. Each items points accumulated as raw scores,the lowest raw score is 20 points, the highest raw score is 80 points. The raw scores multiply by 1.25, taking the integer part as the standard scores.The ZSDS standard scores were used to define four categories of depression severity: within normal range or no significant psychopathology (below 51points); presence of minimal to mild depression (51-60points); presence of moderate to marked depression (61-70points). |
| The Scores of Physical Function Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | Baseline and 8 weeks | The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL. |
| The Scores of Role-physical Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | Baseline and 8 weeks | The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL. |
| Endometrial Thickness Were Measured by Ultrasound in the Middle of Menstruation in All Patients. | 3 months | — |
| The Scores of Vitality Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | Baseline and 8 weeks | The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL. |
| The Scores of Mental Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | Baseline and 8 weeks | The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL. |
| The Scores of Social Functioning Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | Baseline and 8 weeks | The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL. |
| The Scores of Bodily Pain Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | Baseline and 8 weeks | The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL. |
| The Scores of General Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | Baseline and 8 weeks | The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL. |
| The Scores of Role-emotional Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | Baseline and 8 weeks | The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL. |
Participant flow
Recruitment details
Patients were recruited into present study between January 2015 and January 2016
Pre-assignment details
A total of 226 patients with IUA were recruited into present study within 12 months. Of them, 10 met the exclusion criteria and 55 patients refused to participate in this study. Finally, 161 patients were randomized into MBSR group (n=80) and wait-list group (n=81).
Participants by arm
| Arm | Count |
|---|---|
| MBSR Group The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills. | 76 |
| Wait-list Control Group The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy. | 75 |
| Total | 151 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 6 |
Baseline characteristics
| Characteristic | MBSR Group | Wait-list Control Group | Total |
|---|---|---|---|
| Age, Continuous | 30.7 years STANDARD_DEVIATION 5.5 | 31.1 years STANDARD_DEVIATION 6.5 | 30.9 years STANDARD_DEVIATION 6 |
| Education < 9 years | 5 participants | 8 participants | 13 participants |
| Education ≥9 years | 71 participants | 67 participants | 138 participants |
| Marriage Married | 64 participants | 68 participants | 132 participants |
| Marriage Single | 12 participants | 7 participants | 19 participants |
| Salary per month < ¥ 5000 | 16 participants | 15 participants | 31 participants |
| Salary per month > ¥ 5000 | 60 participants | 60 participants | 120 participants |
| Sex/Gender, Customized female | 76 participants | 75 participants | 151 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 76 | 0 / 75 |
| serious Total, serious adverse events | 0 / 76 | 0 / 75 |
Outcome results
Primary
The Zung Self-Rating Anxiety Scale Scores Before and After the Intervention
The full name of the scale called Zung Self-Rating Anxiety Scale.The ZSAS contains 20 questions. Each question is scored on a scale of 1-4 (never, some of the time, relatively often, most of the time). Fifteen questions involve the assessment of increasing anxiety levels, and five questions involve decreasing anxiety levels.Each items points accumulated as raw scores,the lowest raw score is 20 points, the highest raw score is 80 points. The raw scores multiply by 1.25, taking the integer part as the standard scores.The ZSAS standard scores were used to define four categories of anxiety severity: within normal rangeor no significant psychopathology (25-49points);presence of mild to moderate anxiety levels (50-59points); severe anxiety levels (60-69points); and presence of extreme depression (70-100points).
Time frame: Baseline and 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MBSR Group | The Zung Self-Rating Anxiety Scale Scores Before and After the Intervention | before intervention | 36.4 units on a scale(raw scores) | Standard Deviation 6.2 |
| MBSR Group | The Zung Self-Rating Anxiety Scale Scores Before and After the Intervention | after intervention | 32.1 units on a scale(raw scores) | Standard Deviation 5.9 |
| Wait-list Control Group | The Zung Self-Rating Anxiety Scale Scores Before and After the Intervention | before intervention | 37.3 units on a scale(raw scores) | Standard Deviation 6.8 |
| Wait-list Control Group | The Zung Self-Rating Anxiety Scale Scores Before and After the Intervention | after intervention | 38.5 units on a scale(raw scores) | Standard Deviation 6.4 |
p-value: <0.001ANOVA
Secondary
Endometrial Thickness Were Measured by Ultrasound in the Middle of Menstruation in All Patients.
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MBSR Group | Endometrial Thickness Were Measured by Ultrasound in the Middle of Menstruation in All Patients. | before intervention | 4.4 mm | Standard Deviation 2.5 |
| MBSR Group | Endometrial Thickness Were Measured by Ultrasound in the Middle of Menstruation in All Patients. | after intervention | 5.7 mm | Standard Deviation 1.4 |
| Wait-list Control Group | Endometrial Thickness Were Measured by Ultrasound in the Middle of Menstruation in All Patients. | before intervention | 4.1 mm | Standard Deviation 2.4 |
| Wait-list Control Group | Endometrial Thickness Were Measured by Ultrasound in the Middle of Menstruation in All Patients. | after intervention | 5.2 mm | Standard Deviation 1.4 |
p-value: >0.05ANOVA
Secondary
Menstruation Was Evaluated With Visual Analogue Scale (VAS) in Which the Menstruation Was Assessed by the Patients Themselves With 0 as Amenorrhea and 100 as Normal Menstruation
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MBSR Group | Menstruation Was Evaluated With Visual Analogue Scale (VAS) in Which the Menstruation Was Assessed by the Patients Themselves With 0 as Amenorrhea and 100 as Normal Menstruation | before intervention | 43.9 units on a scale | Standard Deviation 22.5 |
| MBSR Group | Menstruation Was Evaluated With Visual Analogue Scale (VAS) in Which the Menstruation Was Assessed by the Patients Themselves With 0 as Amenorrhea and 100 as Normal Menstruation | after intervention | 68.5 units on a scale | Standard Deviation 22 |
| Wait-list Control Group | Menstruation Was Evaluated With Visual Analogue Scale (VAS) in Which the Menstruation Was Assessed by the Patients Themselves With 0 as Amenorrhea and 100 as Normal Menstruation | before intervention | 44.8 units on a scale | Standard Deviation 27.8 |
| Wait-list Control Group | Menstruation Was Evaluated With Visual Analogue Scale (VAS) in Which the Menstruation Was Assessed by the Patients Themselves With 0 as Amenorrhea and 100 as Normal Menstruation | after intervention | 69.2 units on a scale | Standard Deviation 24.8 |
p-value: >0.05ANOVA
Secondary
Numbers of Participants With Reformation of Intrauterine Adhesions Were Counted by the Follow-up Hysteroscopy Was Performed in the Third Month After the Surgery
Time frame: 3 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MBSR Group | Numbers of Participants With Reformation of Intrauterine Adhesions Were Counted by the Follow-up Hysteroscopy Was Performed in the Third Month After the Surgery | Reformation of intrauterine adhesions | 14 participants |
| MBSR Group | Numbers of Participants With Reformation of Intrauterine Adhesions Were Counted by the Follow-up Hysteroscopy Was Performed in the Third Month After the Surgery | Normal uterine | 62 participants |
| Wait-list Control Group | Numbers of Participants With Reformation of Intrauterine Adhesions Were Counted by the Follow-up Hysteroscopy Was Performed in the Third Month After the Surgery | Reformation of intrauterine adhesions | 26 participants |
| Wait-list Control Group | Numbers of Participants With Reformation of Intrauterine Adhesions Were Counted by the Follow-up Hysteroscopy Was Performed in the Third Month After the Surgery | Normal uterine | 49 participants |
p-value: 0.024Chi-squared
Secondary
The Scores of Bodily Pain Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.
Time frame: Baseline and 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MBSR Group | The Scores of Bodily Pain Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | before intervention | 71.3 units on a scale(t scores) | Standard Deviation 15.1 |
| MBSR Group | The Scores of Bodily Pain Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | after intervention | 72.5 units on a scale(t scores) | Standard Deviation 11.1 |
| Wait-list Control Group | The Scores of Bodily Pain Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | before intervention | 70.4 units on a scale(t scores) | Standard Deviation 16.3 |
| Wait-list Control Group | The Scores of Bodily Pain Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | after intervention | 68.5 units on a scale(t scores) | Standard Deviation 14.6 |
p-value: 0.277ANOVA
Secondary
The Scores of General Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.
Time frame: Baseline and 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MBSR Group | The Scores of General Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | before intervention | 56.9 units on a scale(t scores) | Standard Deviation 17.7 |
| MBSR Group | The Scores of General Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | after intervention | 66.5 units on a scale(t scores) | Standard Deviation 16 |
| Wait-list Control Group | The Scores of General Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | before intervention | 58.9 units on a scale(t scores) | Standard Deviation 19 |
| Wait-list Control Group | The Scores of General Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | after intervention | 57.1 units on a scale(t scores) | Standard Deviation 17.6 |
p-value: 0.001ANOVA
Secondary
The Scores of Mental Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.
Time frame: Baseline and 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MBSR Group | The Scores of Mental Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | before intervention | 64.6 units on a scale(t scores) | Standard Deviation 16.3 |
| MBSR Group | The Scores of Mental Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | after intervention | 72.9 units on a scale(t scores) | Standard Deviation 13 |
| Wait-list Control Group | The Scores of Mental Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | before intervention | 64.9 units on a scale(t scores) | Standard Deviation 16.8 |
| Wait-list Control Group | The Scores of Mental Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | after intervention | 63.9 units on a scale(t scores) | Standard Deviation 16.5 |
p-value: <0.001ANOVA
Secondary
The Scores of Physical Function Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.
Time frame: Baseline and 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MBSR Group | The Scores of Physical Function Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | before intervention | 86.5 units on a scale(t scores) | Standard Deviation 13.7 |
| MBSR Group | The Scores of Physical Function Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | after intervention | 90.9 units on a scale(t scores) | Standard Deviation 10.7 |
| Wait-list Control Group | The Scores of Physical Function Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | before intervention | 88.1 units on a scale(t scores) | Standard Deviation 12.5 |
| Wait-list Control Group | The Scores of Physical Function Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | after intervention | 85.3 units on a scale(t scores) | Standard Deviation 11.3 |
p-value: 0.001ANOVA
Secondary
The Scores of Role-emotional Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.
Time frame: Baseline and 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MBSR Group | The Scores of Role-emotional Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | before intervention | 55.7 units on a scale(t scores) | Standard Deviation 34.3 |
| MBSR Group | The Scores of Role-emotional Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | after intervention | 78.5 units on a scale(t scores) | Standard Deviation 22.9 |
| Wait-list Control Group | The Scores of Role-emotional Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | before intervention | 64.0 units on a scale(t scores) | Standard Deviation 35 |
| Wait-list Control Group | The Scores of Role-emotional Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | after intervention | 62.7 units on a scale(t scores) | Standard Deviation 30 |
p-value: 0.024ANOVA
Secondary
The Scores of Role-physical Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.
Time frame: Baseline and 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MBSR Group | The Scores of Role-physical Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | before intervention | 61.5 units on a scale(t scores) | Standard Deviation 38.2 |
| MBSR Group | The Scores of Role-physical Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | after intervention | 74.7 units on a scale(t scores) | Standard Deviation 26.6 |
| Wait-list Control Group | The Scores of Role-physical Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | before intervention | 60.3 units on a scale(t scores) | Standard Deviation 35.9 |
| Wait-list Control Group | The Scores of Role-physical Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | after intervention | 55.7 units on a scale(t scores) | Standard Deviation 34.3 |
p-value: 0.003ANOVA
Secondary
The Scores of Social Functioning Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.
Time frame: Baseline and 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MBSR Group | The Scores of Social Functioning Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | before intervention | 78.1 units on a scale(t scores) | Standard Deviation 19.6 |
| MBSR Group | The Scores of Social Functioning Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | after intervention | 86.2 units on a scale(t scores) | Standard Deviation 13.9 |
| Wait-list Control Group | The Scores of Social Functioning Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | before intervention | 80.3 units on a scale(t scores) | Standard Deviation 18 |
| Wait-list Control Group | The Scores of Social Functioning Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | after intervention | 80.5 units on a scale(t scores) | Standard Deviation 18.6 |
p-value: <0.001ANOVA
Secondary
The Scores of Vitality Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.
Time frame: Baseline and 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MBSR Group | The Scores of Vitality Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | after intervention | 74.9 units on a scale(t scores) | Standard Deviation 11.6 |
| MBSR Group | The Scores of Vitality Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | before intervention | 67.2 units on a scale(t scores) | Standard Deviation 19.5 |
| Wait-list Control Group | The Scores of Vitality Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | before intervention | 64.5 units on a scale(t scores) | Standard Deviation 19.8 |
| Wait-list Control Group | The Scores of Vitality Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) | after intervention | 62.3 units on a scale(t scores) | Standard Deviation 18.6 |
p-value: 0.004ANOVA
Secondary
The Zung Self-Rating Depression Scale Scores Before and After the Intervention
The full name of the scale called Zung Self-Rating Depression Scale.The ZSDS includes 10 positively worded items and 10 negatively worded items that assess symptoms of depression. Item responses are ranked from 1 to 4, and higher scores correspond to more frequent symptoms. For each item,patients give a score according to whether the item has occurred: 1 = never/very rarely; 2 = once in a while/some of the time/occasionally; 3 = relatively often/very often/often; 4 = most of the time/always. Each items points accumulated as raw scores,the lowest raw score is 20 points, the highest raw score is 80 points. The raw scores multiply by 1.25, taking the integer part as the standard scores.The ZSDS standard scores were used to define four categories of depression severity: within normal range or no significant psychopathology (below 51points); presence of minimal to mild depression (51-60points); presence of moderate to marked depression (61-70points).
Time frame: Baseline and 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MBSR Group | The Zung Self-Rating Depression Scale Scores Before and After the Intervention | before intervention | 40.3 units on a scale(raw scores) | Standard Deviation 7.2 |
| MBSR Group | The Zung Self-Rating Depression Scale Scores Before and After the Intervention | after intervention | 37.1 units on a scale(raw scores) | Standard Deviation 7.4 |
| Wait-list Control Group | The Zung Self-Rating Depression Scale Scores Before and After the Intervention | before intervention | 39.7 units on a scale(raw scores) | Standard Deviation 6.2 |
| Wait-list Control Group | The Zung Self-Rating Depression Scale Scores Before and After the Intervention | after intervention | 40.9 units on a scale(raw scores) | Standard Deviation 6 |
p-value: <0.001ANOVA